(139 days)
OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intraabdominal procedures in general (open) surgery. It is also designed to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.
The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).
- (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
- (2) Olympus SonoSurg Transducer SonoSurg-T2H.
- (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.
This medical device submission for the Olympus Ultrasonic Surgical System (K031523) does not contain acceptance criteria or a study demonstrating the device meets such criteria in the context of an AI/ML algorithm evaluation.
The provided documents describe a traditional medical device (an ultrasonic surgical system) and its substantial equivalence to predicate devices based on technological characteristics and intended use. The submission explicitly states:
"G. Reason for not requiring clinical data: When compared to the predicate devices, 'Olympus Ultrasonic Surgical System' does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."
This indicates that the approval was based on a comparison to existing devices, not on a performance study against specific acceptance criteria for an AI/ML component.
Therefore, I cannot provide the requested information for an AI/ML study because it is not present in the provided text.
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